GLP-1 for HIV MASLD
Semaglutide reduces severity of common liver disease in people with HIV | National Institutes of Health (NIH)
"A weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD), according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. This is the first clinical trial of semaglutide for MASLD in people with HIV.
These findings suggest that semaglutide is a safe and effective therapy for MASLD in people with HIV. The study may help inform healthcare decisions by people in consultation with their providers, as part of an approach to healthier aging with HIV over the life span."
The trial:
"Within 30 days prior to pre-entry, a minimum WC measurement of ≥95 cm for individuals assigned male sex at birth or ≥94 cm for individuals assigned female sex at birth."
Study Details | Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study) | ClinicalTrials.gov
They should stay with the HIV MASH why because their previous trials were on those patients and not many clinical trials were/are being conducted on HIV patients instead of going with general population.
The CEO said at the time FDA suggested that but didn't he understand the competitive market with many trials were and still being conducted on general population? That "position of Strength"
could have had the advantage of being in a smaller yet less competitive field, resulting in better odds of finding a partner in that niche/relatively unexplored market. Now these GLP-1 drugs are entering the space so there is market demand for it.
Note in the above trial WC measurement has to be equal or higher than 95 which means they are not only targeting HIV patients but to be eligible the patients have to be overweight and/or obese.
As for results to my understanding so far these GLP-1 had neutral effects on fibrosis so they like Tesamorelin improved NASH resolution.
I clearly remember that they took their time before finalizing the at the time phase 3 application so again knowing MASH trials are costly and timely why didn't they stay in a less competitive market?
It's almost unbearable to see how these drugs treating obesity/diabetes are now being considered as an option for HIV MASLD and as for Tesamorelin and the company's MASH asset nothing....